Digital Image Correlation in Right Ventricular Evaluation (CardiomeDIC)

November 24, 2021 updated by: Jari Laurikka, Tampere University Hospital

Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery

Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital, Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • open heart surgery, patient acceptance and informed consent, age 75 or more

Exclusion Criteria:

  • patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning
Drug: Theophylline
iv injection
Procedure: Ventilator positive end expiratory pressure adjustment
Positive end-expiratory pressure variation
Device: Videorecording
Myocardial movement videorecording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart ventricle function
Time Frame: Within the operation
Changes in heart ventricle contraction status
Within the operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG
Time Frame: Within the operation
Simultaneous ECG recording and analysis during outcome 4 measurements
Within the operation
Transesophageal ultrasound
Time Frame: Within the operation
Myocardial contraction range during video-clip
Within the operation
Cardiac output
Time Frame: Within the operation
Measurement of cardiac output
Within the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Tampere University of Technology

Investigators

  • Principal Investigator: Jari Laurikka, MD,PhD, Professor, Cardio-thoracic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2016

Primary Completion (Actual)

October 21, 2019

Study Completion (Actual)

October 21, 2019

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R16045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

non-identifiable data to Tampere University of Technology research group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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